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Cybrexa Therapeutics Unveils Rucaparib as FDA- and EMA-Approved PARP Inhibitor…
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Cybrexa Therapeutics Unveils Rucaparib as FDA- and EMA-Approved PARP Inhibitor in Lead Candidate CBX-11, Which Demonstrates Synergistic Efficacy with Chemotherapy Without Compounded Toxicity
Cybrexa Therapeutics Unveils Rucaparib as FDA- and EMA-Approved PARP Inhibitor in Lead Candidate CBX-11, Which Demonstrates Synergistic Efficacy with Chemotherapy Without Compounded Toxicity
Tumor-selective CBX-11 allows full dose co-administration with chemotherapy, enabling synergistic efficacy in HRD negative tumors
Poster presentation today during AACR Annual Meeting 2019
New Haven, Conn., April 2, 2019 – Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its alphalex™ tumor targeting platform, today announced that the FDA- and EMA-approved poly ADP-ribose polymerase (PARP) inhibitor rucaparib (marketed as Rubraca®) is conjugated in lead candidate CBX-11 (alphalex™-rucaparib). The first set of preclinical data supporting CBX-11 demonstrate that Cybrexa’s proprietary alphalex™ platform can enable full dose administration with DNA damaging chemotherapy, creating synergistic efficacy in destroying solid tumors independent of homologous recombination deficiency (HRD) status. In particular, CBX-11 selectively delivers rucaparib to tumor tissue, avoiding the bone marrow toxicity that has prevented optimal dosing of DNA damaging chemotherapy in combination with PARP inhibitors.
These data were exhibited today in a poster presentation by Vishwas Paralkar, PhD, Chief Scientific Officer of Cybrexa, during the American Association for Cancer Research (AACR) Annual Meeting 2019.
“These mark the first results demonstrating that combination of the potent PARP inhibitor rucaparib and chemotherapy is able to effectively kill cancer cells independent of HRD status and without the extreme bone marrow toxicity historically observed in this combination, which previously resulted in significant dose reduction and therefore efficacy reduction,” said Vishwas Paralkar, PhD, Chief Scientific Officer of Cybrexa. “The synergistic efficacy allowing full dose administration of both rucaparib and chemotherapy is a direct result of our alphalex™ technology platform that selectively targets tumor cells to overcome this barrier for combination therapies.”
In the study, tumor targeting of rucaparib was achieved using the alphalex™ platform, which allows small molecule anti-cancer agents to penetrate cell membranes only at the low pH associated with the tumor microenvironment. These data demonstrate that the alphalex™ conjugate inserts only across cancer cell membranes to deliver its cargo directly into the cancer cell. The safety and efficacy of the approach was confirmed in vivo using CBX-11, which was safely administered with cytotoxic chemotherapies to selectively kill both HRD-positive and HRD-negative tumors with significant sparing of bone marrow.
Per Hellsund, President and CEO of Cybrexa, commented, “These preclinical results highlight an entirely new approach to applying PARP inhibitors against solid tumors independent of HRD status and directly support our Phase 1 clinical trial evaluating CBX-11 in combination with chemotherapy, which is planned to start in the first quarter of 2020. Furthermore, our alphalex™ platform approach can be applied to a diverse range of DNA damage repair inhibitors to enable combinations with chemotherapy and chemo-radiation in a tissue-agnostic manner and we look forward to discussing these applications.”
Link to poster: http://www.cybrexa.com/wp-content/uploads/2019/04/Cybrexa-Poster-2981-AACR-Mtg-Atlanta-Mar2019-002.pdf
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform enables the delivery of small molecules across the cell membrane under low pH conditions, which is a universal feature of cancer cells. As a result, alphalex™ technology – which consists of a novel peptide, linker and small molecule anti-cancer agent – allows for antigen-independent, intracellular delivery of small molecule anti-cancer agents directly into the tumor cell. View a video of the mechanism of action of the technology at http://www.cybrexa.com/our-technology/.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of cancer therapies using its alphalex™ platform to deliver anti-cancer agents directly into tumor cells. The Company’s lead candidate, CBX-11, an alphalex™-rucaparib combination, is in preclinical development with advancing plans to initiate clinical development by 1Q 2020. Cybrexa was founded by physician-scientists, and has an experienced management team that has built numerous successful life sciences companies and raised hundreds of millions of dollars in venture capital. For more information about Cybrexa, please visit www.cybrexa.com.
Contacts
The Ruth Group
Investor Relations
Lee Roth
Media Relations
Kirsten Thomas
Cybrexa Therapeutics to Present First Data and Unveil Details for its alphalex™-PARP Inhibitor Lead Candidate CBX-11 at AACR Annual Meeting 2019
New Haven, Conn., March 18, 2019 – Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its alphalex™ tumor targeting platform, today announced that Vishwas Paralkar, PhD, Chief Scientific Officer of Cybrexa, will present the first set of preclinical data supporting its alphalex™-PARP inhibitor lead candidate, CBX-11, at the American Association for Cancer Research (AACR) Annual Meeting 2019, being held March 29 – April 3 in Atlanta, Georgia. At the meeting, the Company will unveil the FDA-approved poly ADP-ribose polymerase (PARP) inhibitor conjugated in CBX-11.
CBX-11 combines Cybrexa’s proprietary alphalex™ tumor targeting technology with an already-approved oral small molecule PARP inhibitor. CBX-11 will be evaluated in combination with DNA damaging chemotherapy for the treatment of patients with solid tumors that lack homologous recombination deficiency (HRD). The company remains on track to submit its Investigational New Drug (IND) application for CBX-11 by the fourth quarter of 2019, with a Phase 1 clinical trial evaluating CBX-11 in combination with chemotherapy anticipated to begin in the first quarter of 2020.
Details for the poster presentation are as follows:
Targeting solid tumor acidic microenvironment with an alphalex PARP inhibitor
Permanent Abstract # 2981 / Poster #3
Session: Diagnostics, Biomarkers, and the Tumor Microenvironment
Date and Time: Tuesday, April 2; 8:00 am – 12:00 pm EST
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 11
Presenting Author: Vishwas Paralkar, PhD, Chief Scientific Officer of Cybrexa
“This marks the first set of preclinical data supporting our lead candidate CBX-11, which we formally announced at the beginning of the year,” said Vishwas Paralkar, PhD, Chief Scientific Officer of Cybrexa. “Our alphalex™ tumor targeting technology represents a novel approach to enable the synergistic efficacy of a PARP inhibitor and chemotherapy administered at full dose. We are excited to share these compelling data and take the opportunity to unveil the composition of CBX-11, especially given the current development landscape and high profile of PARP inhibitors.”
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform enables the delivery of small molecules across the cell membrane under low pH conditions, which is a universal feature of cancer cells. As a result, alphalex™ technology – which consists of a novel peptide, linker and small molecule anti-cancer agent – allows for antigen-independent, intracellular delivery of small molecule anti-cancer agents directly into the tumor cell. View a video of the mechanism of action of the technology at http://www.cybrexa.com/our-technology.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of cancer therapies using its alphalex™ platform to deliver anti-cancer agents directly into tumor cells. The Company’s lead candidate, CBX-11, an alphalex™-PARP inhibitor combination, is in preclinical development with advancing plans to initiate clinical development by 1Q 2020. Cybrexa was founded by physician-scientists, and has an experienced management team that has built numerous successful life sciences companies and raised hundreds of millions of dollars in venture capital. For more information about Cybrexa, please visit www.cybrexa.com.
Contacts
The Ruth Group
Investor Relations
Lee Roth
Media Relations
Kirsten Thomas
Cybrexa Therapeutics Announces Multiple Oral Presentations Highlighting the Advances in…
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Cybrexa Therapeutics Announces Multiple Oral Presentations Highlighting the Advances in the Application of DNA Repair Pathways in Cancer Drug Development at the DNA Damage Response Therapeutics Summit 2019
Cybrexa Therapeutics Announces Multiple Oral Presentations Highlighting the Advances in the Application of DNA Repair Pathways in Cancer Drug Development at the DNA Damage Response Therapeutics Summit 2019
New Haven, Conn., January 22, 2019 – Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its alphalex™ tumor-targeting platform, today announced that Dr. Vishwas Paralkar, Chief Scientific Officer of Cybrexa, and Dr. Ranjit Bindra, Cybrexa Scientific Co-founder and Associate Professor at the Yale School of Medicine, will deliver presentations as expert speakers showcasing the advancement of DNA repair pathways in the field of cancer therapeutics. The presentations will be made at the upcoming Cybrexa Therapeutics Announces Multiple Oral Presentations Highlighting the Advances in the Application of DNA Repair Pathways in Cancer Drug Development at the DNA Damage Response Therapeutics Summit 2019 being held January 29-31, 2019 in Boston, MA.
Details of the presentations include:
- PARP Inhibitors in the New Era, New Targets & New Targeting Techniques
Presenter: Dr. Vishwas Paralkar
Session: New Developments in PARP Inhibitors & Novel DDR Pathway Targets
Date/Time: Wednesday, January 30th from 2:30 – 3:00 p.m. EST
- Discovery of IDH1/2 Mutations Which Induce a BRCAness State that confers PARP Inhibitor Sensitivity
Presenter: Dr. Ranjit Bindra
Session: Advances in Clinical Biomarker Development
Date/Time: Thursday, January 31st from 2:00 – 2:30 p.m. EST
Per Hellsund, President and CEO of Cybrexa, commented, “At Cybrexa, our mission is to develop new treatment options for patient populations with high unmet need. Based on preclinical data, we believe our alphalex™ technology will be able to successfully combine a potent PARP inhibitor with chemotherapy to enable more efficacious therapeutic combinations in new patient populations. To that end, we are very excited to share the potential of our technology at the upcoming DNA Damage Response Therapeutics Summit.”
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform enables the delivery of small molecules across the cell membrane under low pH conditions, which is a universal feature of cancer cells. As a result, alphalex™ technology – which consists of a novel peptide, linker and small molecule anti-cancer agent – allows for antigen-independent, intracellular delivery of small molecule anti-cancer agents directly into the tumor cell. View a video of the mechanism of action of the technology at www.cybrexa.com.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of cancer therapies using its alphalex™ platform to deliver anti-cancer agents directly into tumor cells. The Company’s lead candidate, CBX-11, an alphalex™-PARP inhibitor combination, is in preclinical development with advancing plans to initiate clinical development by 1Q 2020. Cybrexa was founded by physician-scientists, and has an experienced management team that has built numerous successful life sciences companies and raised hundreds of millions of dollars in venture capital. For more information about Cybrexa, please visit www.cybrexa.com.
Contacts
The Ruth Group
Investor Relations
Lee Roth
Media Relations
Kirsten Thomas